**iVascular** is a *Medical Devices* company located in Sant Vicenç dels Horts. We specialize in the development, manufacturing, and commercialization of advanced medical devices for the treatment of cardio-, neuro-, and endovascular diseases. Our focus is on delivering minimally invasive solutions that genuinely improve patients’ quality of life and establishing ourselves as a reference in the vascular field by enhancing the value of technology and innovation. To achieve this, we internally control the entire process: from research and development through production, sterilization, and distribution. We call this Vertical Integration, enabling us to guarantee maximum quality, continuous innovation, and exceptional agility to adapt to market needs. We are a national company in a growth and international expansion phase, with subsidiaries already established in Europe, the Americas, and Asia. Our purpose is unequivocal: to develop technologies that save and improve lives. **Position:** ----------- **YOUR MISSION:** Ensure that medical device manufacturing processes comply with quality, safety, and regulatory standards through systematic validation, thereby guaranteeing their robustness and repeatability. **FUNCTIONS AND RESPONSIBILITIES:** * Design, plan, and execute validations of key processes. * Develop and review validation protocols and reports (IQ, OQ, PQ) in accordance with applicable regulations. * Conduct repeatability and reproducibility testing to ensure process stability. Apply risk analysis methodologies to identify critical points and verify the suitability of controls and process limits. * Analyze statistical data and define acceptance limits for critical variables. * Perform cleaning validations to minimize cross-contamination. * Conduct residue studies on manufacturing equipment and define effective cleaning strategies. Coordinate required validation activities with involved departments to optimize validated processes while ensuring regulatory compliance and validation status. * Ensure validated processes maintain performance over time through periodic revalidation activities. * Manage deviations and non-conformities identified during validation, proposing and implementing corrective and preventive actions (CAPA). * Maintain up-to-date validation documentation and participate in internal and external audits. Evaluate and propose improvements to production processes to increase efficiency without compromising quality. * Develop and execute the Master Validation Plan. Report any deviation from the plan. * Review current procedures and protocols to ensure alignment with Annex 15 of GMP on qualification and validation. * Evaluate new technologies and participate in the qualification of new production machines and systems. **Requirements:** --------------- **DESIRED PROFILE:** Academic background: * Scientific-technical profile with a bachelor’s degree in chemistry, health sciences, engineering, or related fields. Knowledge of applicable regulations: * ISO 13485: Medical devices. * FDA 21 CFR Part 820. * GMP Annex 15. * ISO 14971: Risk management for medical devices. * ISO 14644: Cleanrooms. \- Valuable knowledge in: * GAMP5 for computerized system validation. * Applied statistics for processes. * ISO 14644: Cleanrooms. * Full professional English proficiency. * Advanced Microsoft Office user. Experience: Minimum 4 years of experience in process and cleaning validation within the medical device, pharmaceutical, or related industries. Experience in developing and executing IQ, OQ, and PQ validation protocols. Skills and attitudes: * Analytical, proactive individual focused on problem resolution. * Team player with strong interdepartmental communication skills. * Meticulous, efficient, rigorous, dynamic, and organized individual. * Adaptable to regulatory and technological changes. **Additional Information:** --------------------- **WHAT WE OFFER** * Permanent and stable employment contract within a globally impactful project currently undergoing international expansion. * Professional and personal development in a young and dynamic environment. * Competitive salary based on experience and an attractive benefits package. * Flexible working hours to support work-life/family balance. * Flexible compensation (restaurant vouchers, transportation, and childcare vouchers). * Access to the iWellness program: gym and physiotherapy services at our facilities. * Corporate events and gifts. * Company-subsidized on-site cafeteria.
David Muñoz
Indeed · HR
David Muñoz
Indeed · HR
